1. Field of the Invention
Devices and methods consistent with this invention relate generally to treating a foot and ankle, and more particularly, to treating a foot and ankle using a splint and an adjustable bladder.
2. Description of the Related Art
The plantar fascia is a fibrous band of tissue that supports the arch of the foot. The plantar fascia extends from the bottom surface of the heel bone to the bottom of the feet just behind the toes. If the plantar fascia becomes stretched or strained, the arch and heel bone area of the foot can become tender and swollen. This is referred to as plantar fasciitis, a common and painful medical condition of the foot.
Often, plantar fasciitis is caused by the over-extension of the Achilles tendon, which extends upward from the heel in the back of the lower leg. That is, during physical activity and/or during sleep, a person's Achilles tendon can extend beyond a position that normally occurs when one stands, walks, runs, or sits. When the Achilles tendon extends in this way, the person's ankle tends to also have plantar flexion (i.e., flexion beyond 90 degrees), which stretches the plantar facia.
Patients have successfully treated plantar faciitis by wearing a rigid splint at night while sleeping. The splint includes an upper portion and a lower portion, and the lower portion extends at an angle of less than 90 degrees with respect to the upper portion. By wearing this splint, the patient's ankle is maintained in a state of dorsiflexion (i.e., flexion less than 90 degrees) and the planta facia is prevented from extending at night.
Prior devices for stretching and splinting the leg, ankle and foot apply pressure by way of solid or semi-rigid supports, often cushioned with fabric, foam or other solid or semi-solid materials. The amount of ankle dorsiflexion and stretching may be adjusted by way of strap(s), hinge(s), solid or foam wedge(s), or the shape of the device itself. Obtaining ankle dorsiflexion in such a manner may result in suboptimal contact and loading of the midfoot or forefoot. For instance the use of a wedge placed between the foot and splint could cause point loading of the metatarsal head(s). Such point loading could result in discomfort and reduced compliance, thereby compromising the efficacy of the device.
Stiffness and/or contracture of the gastrocnemius fascia, Achilles tendon, plantar fascia, and other soft tissues of the foot and ankle (heretofore known as “said anatomic structures”) are associated with several pathologic conditions. These conditions include but are not limited to: plantar fasciitis, heel spurs, Achilles tendonitis, Achilles tendinosis, metatarsalgia, ankle contracture, painful callosities, and ulcerations. Accordingly, the treatment of these conditions may include the use of exercises, therapy and devices designed to splint and/or stretch the said anatomic structures. One device or class of devices is worn by the patient while at rest, usually at night, and therefore commonly referred to as a “night splint.”
U.S. Pat. No. 5,799,659 issued to Stano, which is incorporated herein by reference, discloses a night splint that includes removable wedges provided within the splint. The removable wedges allow the angle of dorsiflexion to be adjusted by the patient. However, ability of the patient to vary the angle of dorsiflexion is limited by the number of removable wedges that are provided with the splint.
To splint and/or stretch the foot and ankle while at rest, a variety of devices have been developed. Despite the extensive development of such devices, they continue to exhibit certain disadvantages. For example, their designs are: (1) too complex, (2) too costly, (3) and may result in suboptimal contact and loading of the midfoot or forefoot. Thus, there exists a continuing need for the development of new and improved, easier to use and inexpensive devices for stretching and/or splinting said anatomic structures associated with said pathologic conditions. Accordingly, it would be beneficial to provide a splint that does not have multiple removable parts, which the patient may misplace. Moreover, it would be beneficial to provide a splint that provides the patient with the flexibility to adjust the angle of dorsiflexion to many different angles.